Hearth Record

Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J

Medical device recall Z-3047-2024. Published in FDA’s Enforcement Report on Sep 18, 2024.

FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Sep 18, 2024. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Number DYNDL1813; 6) CIRCUMCISION PACK , Pack Number DYNJ16826M ; 7) CIRCUMCISION PACK , Pack Number DYNJ16826N ; 8) CIRCUMCISION PACK , Pack Number DYNJ16826O ; 9) CIRCUMCISION PACK , Pack Number DYNJ38941D ; 10) CIRCUMCISION PACK , Pack Number DYNJ38941F ; 11) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471D ; 12) CIRCUMCISION SJHC-LF, Pack Number DYNJ48471F ; 13) CRMC UNIVERSAL PACK-LF, Pack Number DYNJ61119C ; 14) D-CIRCUMCISION PACK , Pack Number DYNJ64432; 15) CIRCUMCISION PACK , Pack Number DYNJ64876A ; 16) CIRCUMCISION PACK , Pack Number DYNJ64876B ; 17) PACK,CIRCUMCISION ASC , Pack Number DYNJ906909A

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

CDS980371J , Lot Number 19BBJ528 ; CDS980371J , Lot Number 19BBS356 ; CDS980371J , Lot Number 19DBR965 ; CDS980371J , Lot Number 19EBX731 ; CDS980371J , Lot Number 19GBJ926 ; CDS980371J , Lot Number 19HBY831 ; CDS980371J , Lot Number…

Every code shown here, 1,999 characters

CDS980371J , Lot Number 19BBJ528 ; CDS980371J , Lot Number 19BBS356 ; CDS980371J , Lot Number 19DBR965 ; CDS980371J , Lot Number 19EBX731 ; CDS980371J , Lot Number 19GBJ926 ; CDS980371J , Lot Number 19HBY831 ; CDS980371J , Lot Number 19IBL323 ; CDS980371K , Lot Number 21GBD850 ; CDS980371K , Lot Number 21HBI925 ; CDS980371K , Lot Number 21JBJ715 ; CDS980371K , Lot Number 19LBF128 ; CDS980371K , Lot Number 20BBU821 ; CDS980371K , Lot Number 20FBB764 ; CDS980371K , Lot Number 20GBR055 ; CDS980371K , Lot Number 20JBT054 ; CDS980371K , Lot Number 20LBC968 ; CDS980371K , Lot Number 21BBE923 ; CDS980371K , Lot Number 21BBG105 ; CDS980371K , Lot Number 21DBL086 ; CIT6260A , Lot Number 22LBQ691 ; CIT6260A , Lot Number 23ABQ560 ; CIT6260A , Lot Number 23EBS513 ; CIT6260A , Lot Number 23HBT731 ; CIT6260A , Lot Number 23LBT432 ; CIT7740, Lot Number 23DBE831 ; CIT7740, Lot Number 23IBR327 ; DYNDL1813, Lot Number 20FBD708 ; DYNJ16826M , Lot Number 20KME235 ; DYNJ16826M , Lot Number 20LMD829 ; DYNJ16826M , Lot Number 20LME603 ; DYNJ16826M , Lot Number 21BMD922 ; DYNJ16826M , Lot Number 21DMC310 ; DYNJ16826M , Lot Number 21GMC003 ; DYNJ16826M , Lot Number 21HMG078 ; DYNJ16826N , Lot Number 21JMF750 ; DYNJ16826N , Lot Number 21LMF895 ; DYNJ16826N , Lot Number 22CMF391 ; DYNJ16826N , Lot Number 22DMG155 ; DYNJ16826N , Lot Number 22FMB133 ; DYNJ16826N , Lot Number 22IMA881 ; DYNJ16826N , Lot Number 22KMF328 ; DYNJ16826N , Lot Number 23AMA622 ; DYNJ16826N , Lot Number 23BMG816 ; DYNJ16826N , Lot Number 23DMA339 ; DYNJ16826O , Lot Number 23FMC064 ; DYNJ16826O , Lot Number 23GMC962 ; DYNJ16826O , Lot Number 23GMG544 ; DYNJ16826O , Lot Number 23HMI663 ; DYNJ16826O , Lot Number 23JMH529 ; DYNJ16826O , Lot Number 24AMA886 ; DYNJ38941D , Lot Number 19BBN390 ; DYNJ38941D , Lot Number 19CBE691 ; DYNJ38941D , Lot Number 19EBK155 ; DYNJ38941D , Lot Number 19FBW883 ; DYNJ38941D , Lot Number 19SBF056 ; DYNJ38941D , Lot Number 19IBO888 ; DYNJ38941D , Lot Number 19KBM786 ; DYNJ38941D , Lot Number…

FDA’s list runs to 5,547 characters. The first part is shown; the rest is on FDA’s record.

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

Worldwide distribution.

These words name no state.

The words say it went outside the United States too.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Apr 8, 2024.
  • FDA classified it on Sep 6, 2024.
  • FDA’s Enforcement Report published it on Sep 18, 2024.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • FDA’s list of codes runs to 5,547 characters; the first part is shown here, and the rest is on FDA’s record.
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Device recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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